Episode 16

Pressure-Directed Therapy in Y90

with Dr. Charles Nutting and Dr. Nainesh Parikh

Dr. Charles Nutting of RIA Endovascular in Denver, and Dr. Nainesh Parikh of Moffitt Cancer Center discuss Y90 radioembolization therapy for HCC using pressure directed anti-reflux systems such as the Surefire Infusion System (SIS).

Cite this podcast: BackTable, LLC (Producer). (2017, November 5). Ep 16 – Pressure-Directed Therapy in Y90 [Audio podcast]. Retrieved from https://www.backtable.com/podcasts

Full Transcript Below

In this Episode

Podcast Participants

Dr. Charles Nutting is a practicing interventional radiologist with RIA Endovascular in Denver, Colorado.

Dr. Nainesh Parikh is a practicing interventional radiologist with Moffitt Cancer Center in Tampa, Florida.

Disclosure

Podcast sponsored by Surefire Medical.

Disclaimer: The Materials available on the BackTable Podcast are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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Full Transcript

Pressure-Directed Therapy in Y90

[Anish Parikh]

Well welcome, everybody, to the BackTable Podcast. I'm your host, Anish Parikh, and I'm joined today by Doctor Charles Nutting of Skyridge Cancer Center in Colorado, and Doctor Nainesh Parikh of the H Lee Moffitt Cancer Center in Tampa, Florida. They've joined us to speak about barriers to therapy uptake in treatment of Hepatocellular Carcinoma, and the benefits and drawbacks of pressure directed therapy.

Tumor microenvironments are complex; and interventional radiologists - the MacGyvers that you are - need to be aware of how to navigate them successfully, which is why we've brought a couple of experts on, in today's episode, to shed some light: Doctor Charlie Nutting and Doctor Nainesh Parikh.

Nain, Charlie, thanks for being here.

 

 

[Nainesh Parikh]

Thanks for having us, Anish.

 

 

[Charles Nutting]

Thank you for having me.

 

 

[Anish Parikh]

Now, for those of you who've been following our podcast since the beginning, we've got something brand new for this episode, and before I say anything further, I'm gonna pass along a word from our sponsors.

 

This podcast is brought to you by Surefire Medical. Surefire has the only expandable tip catheter, to help physicians maintain blood flow, while reducing reflux during chemo and radioembolization procedures. Now, physicians can deliver therapy deeper into liver tumors, while protecting healthy tissue. Learn more at surefiremedical.com.

 

Now, lest anyone think that Doctor Parikh's last name is purely a coincidence, I should point out that he is also my brother. So, hi Mom, look at us. *Laughing* Guys, go ahead and give a little background on yourselves, and your practices, for our audience. Doctor Nutting, go ahead.

 

 

[Charles Nutting]

Hi, I'm an interventional radiologist practicing in Denver, Colorado. I'm in a private practice group, a large group of radiologists - about a hundred radiologists with twelve interventionalists. My primary focus is interventional oncology, and I would say that I specialize in performing radioembolization procedures as well as other forms of liver-directed therapy.

 

 

[Anish Parikh]

Great, thanks. And Nain, Doctor Parikh?

 

 

[Nainesh Parikh]

Sure; so, as Anish said, I am the younger brother of the Parikh family - we actually do have a third brother, so all three of us say hi, Mom - and I am similar to Charlie, I am an interventional radiologist at Moffitt Cancer Center, located in Tampa, Florida. I, too, come from a big group of interventional radiologists; we actually have six, and we also focus on liver-directed therapy for liver cancer. I think, me, personally, I focus on liver cancer. I also focus on arterial embolization for prostate: both cancer, and benign prostatic hyperplasia, but for the purposes of this talk, I definitely do the lion's share of work for liver-directed therapy for liver cancer.

 

 

[Anish Parikh]

So how do you guys approach - love to hear from both of you - how do you approach your HCC treatments?

 

 

[Nainesh Parikh]

First, so, I can say I think we probably do it different ways. I think I can speak for my practice in saying that we work very closely with all four pillars of oncology: so, surg-oc, med-oc, interventional oncology, and radiation oncology. And every single HCC patient that walks through the doors of Moffitt gets presented at a liver tumor board with all four of those folks present.

 

For us, oftentimes if it's unresectable disease, we get first dibs, so to speak, at treating HCC with liver-directed therapy. And because of the practice patterns that had been developed far before I got there, probably over the last fourteen years, our preference - if it's not a child candidate - our preference would probably be for radioembolization first.

 

At our institution we use TheraSpheres almost exclusively, with very, very select cases to use SIR-Spheres. And then for residual disease, typically we make the decision - obviously, this would be probably about twelve to fifteen weeks after therapy, or far later on in the course of the patient's disease - we would then switch to either bland embolization or chemoembolization. And again, just because of our practice patterns, we typically will use bland embolization, with pretty decent result.

 

 

[Charles Nutting]

And I would say, in Denver, since we're private practice, I'm dealing with lots of different referring physicians; primarily from the community, occasionally from the university. If it's a regional liver therapy candidate, most of those patients are being treated with radioembolization. And we use both products, both SIR-Sphere and TheraSphere. Some of the patients that are coming from the university system; those surgical oncologists prefer the patients be treated with drug-eluting beads or chemoembolization as a first line therapy, reserving radioembolization for failures.

 

 

[Anish Parikh]

Okay, got it. So - just for the layman here, talk a little about radioembolization and how that works at high level.

 

 

[Charles Nutting]

Nain, do you want to address that?

 

 

[Nainesh Parikh] Sure, sure. So, just to set the stage, Anish, any time that we're talking about unresectable liver disease, especially HCC, the theory is that the blood flow distribution for these tumors are predominantly arterial, rather than portal venous. So, in these patients, we think about how to take advantage of that fact, and deliver therapy through the artery.

 

The way we always explain to patients is you've got three choices: you've got radioactive material that's loaded on small spheres that gets delivered to places with increased blood flow; you've got chemotherapy, that's loaded on small pieces of glass, or spheres as well, that also goes predominantly to where the blood flow takes it; and then you've got just spheres in and of themselves, without anything loaded, that goes to where the blood flow takes it.

 

And each of those three, while they are all predicated upon the blood flow, they all have different outcomes: so for radioembolization, our goal is simply to deliver the radioactive dose to the tumor. And when we think about delivering radioembolization, or Y90 as sometimes people will call it, standing for Yttrium-90 - what it requires is a mapping angiogram, at least for us, and that's one procedure where you go and literally map out the vasculature to the tumors that you're trying to treat.

 

The most traditional sense is that, if it's Bilobar Disease - there are two arteries that supply the left lobe of the liver, and the right lobe of the liver, and so what you'll do is just treat the right lobe with a certain treatment, and then you'll let the patient heal; and six weeks later, you'll treat the left lobe. And then that's kind of how the practice started.

 

And again, you have to understand you're not trying to - I should say, the end point that we're trying to achieve is simply the delivery of the entire calculated dose. I'll just say a note on dose calculation: there's various ways to calculate the appropriate radioactive dose for HCC, but for the most part the goal is simply to deliver the entire dose into each of those arteries supplying the lobe of the tumor.

 

Charlie, is there anything you'd like to add?

 

 

[Charles Nutting]

No, I agree with that, Nain. Very comprehensive.

 

 

[Anish Parikh]

And I guess then, what - what barriers do you run into in this approach? I mean is it all roses or ... what barriers, and what concerns, do you have when you go in that you try to address?

 

 

[Nainesh Parikh]

It's Doctor Nutting, go ahead.

 

 

[Charles Nutting]

So ... we use both Y90 products to treat Hepatocellular Carcinoma, and there is definitely a higher embolic load when we talk about the SIR-Sphere product. So, one of the questions, or one of the concerns that's brought up is: as we're infusing the radioactive microspheres into the tumor distribution, what happens if we hit stasis prior to delivery of the entire dose? And this has been a question in my mind: if we give less than the anticipated dose, is that efficacious?

 

I think that, now that we have some of these pressure-directed methods to deliver the microspheres, especially with chemoemoblization or radioembolization with a higher embolic load, I feel like we're able to give up to a hundred percent of the dose, whereas previously, we may have been limited by stasis.

 

 

[Nainesh Parikh]

And Anish, if I can, I'd probably also add, you know, Charlie's got a lot more experience than I do, and so he probably takes this with a grain of salt, but when you're first starting to do these, the thing you start to worry about is non-target embolization, and that's why the end points for stasis are important. Most notably, non-target embolization of any of the shared collateral supply, that supplies to the liver: most commonly the right gastric artery, coming off the left hepatic artery, as well as the GDA supplying both the pancreas and duodenum.

And so, what you really start to get worried about is non-target embolization, particularly when you get to a point of stasis. And so that's always the balance, is not just non-target embolization verus stasis, but, in addition, at a higher level to what Charlie's saying, is getting all of your dose in so that you can effectively treat the patient. So first you want to do it safely, then I think the second point is to say, well, how can we do it the most efficaciously, as Charlie's talking about. And I think those are kind of the steps that you start to think about.

 

 

[Anish Parikh]

What's the effect of non-targeted embolization, what does it ultimately - what's the impact that it has, and how's that related to the efficacy?

 

 

[Charles Nutting]

I think that the issues we see, with non-targeted embolization, are probably increased adverse events; so some of the nausea or vomiting that can occur after an embolization, increase in liver function studies. I think that if we decrease non-target embolization, we're probably gonna improve some of the adverse outcomes.

 

 

[Anish Parikh]

And does it also improve the quality of the treatment itself? I mean, again, I'll struggle with the terms as a layman, but if you're essentially getting therapy that's going to the wrong place for, you know. To put it bluntly, is that reducing the overall effectiveness, in addition to adding side effects, essentially?

 

 

[Charles Nutting]

Sure, so I think that if we can improve delivery to the tumor and decrease inadvertent embolization, the patients are going to have better outcomes. And if we look at the retrospective data out of Georgetown, they saw improved results in the patients who had Hepatocellular Carcinoma, the imaging studies afterwards, there were better response rates in patients who were treated with a pressure-directed therapy. And I think that this was also mimicked in the Piedmont data, which shows that there was improved outcomes with decreased recurrence rates in patients who were treated with a Surefire device, or catheter-directed therapy, versus an end-hole catheter alone.

 

 

[Anish Parikh]

And Nain, I dunno if you've looked at this, but what's your take on that, and on this type of therapy approach?

 

 

[Nainesh Parikh]

Yeah, I think there's a couple things to note. I would say that non-target embolization comes in various flavors, right? I mean, the dreaded outcome of non-target embolization is going to a different organ, and so obviously that's why we do the workup angiogram. The non-target embolization to healthy liver tumor - I'm sorry, healthy liver parenchyma, or healthy liver tissue, is the kind of more nuanced effect that we're describing here, on a more advanced level. And, you know, I think that that's where ... what Charlie's talking about with the data, we're trying to bear out. So I will say that first of all, for us, I think there's a trade-off between how selective you get for each of the tumors that you're treating, versus the amount of normal liver parenchyma that you are going to treat with your either radioac... Your, arterial therapy, let's call it, one of the three.

 

When we look at how we're going to treat these patients, we're going to of course get it as selective as possible, based on the various distribution of the tumor. And what I mean by that is if segments five and six are spared and we can only look at segments seven and eight, we will. Similarly, if segments two and three are spared, and four is involved, then we'll try to get out and only treat segment four.

We at Moffitt actually only use end-hole catheters, and it's not to say we're necessarily biased, so to speak, but what I would say is that we're not necessarily convinced, particularly because our patient population tends to start with the radioembolization.

 

Charlie, you seem to know the data a little bit better than me, but if I recall, the Georgetown data and the Piedmont data were solely for chemoembolization. It'd be interesting to know how that changes for radio embolization.

 

 

[Charles Nutting]

Right.

 

 

[Nainesh Parikh]

And I do think that, you know, I haven't dug into the data of each of their patients, but it's almost as if you want to know if you've parked your catheter in the main right, or in segment two of the left, call it, and then you compare that way how the outcomes look, because I do think that there are several different variables for how you can compare these pieces of data.

 

But I think one of the big things for us is that our patient population, our institution, tends to start with radioembolization, we don't end up using the Surefire device quite as much, based on the data that's out there.

 

 

[Charles Nutting]

I would agree with that, Nain. I think that there is some data that came out of the University of Tennessee with Doctor Pasciak et al, and they showed that when they were using Surefire catheter with the infusion of the MAA and radioembolization, that there was actually improved dosing to the tumor, with decreased inadvertent embolization or non-target embolization. So you're right, I think that there is more work that needs to be done in this area, but some of the initial data is fairly compelling.

 

 

[Anish Parikh]

Let me ask another layman's question here. Let's just say, Nain, you guys, your approach; let's just say I'm somewhere in the rural part of the country, and I've got a patient that presents with these symptoms, and I've got an option to either use pressure-directed or not - I mean how do I make that choice? Is it as just and dry as...

 

I guess there's two questions in that. One, what if I happen to have only pressure directed, Surefire or other, on hand, can I go ahead and do that. Let's just say I have that on hand, can I do that? Are there things I need to be concerned about?

If I don't have it on hand, under what circumstances do I want to request it, or something like that? And again, it's a bit of the layman's question, but help me think about that.

 

 

[Nainesh Parikh]

Sure, I mean I think that that's of course a loaded question, and I can try to step through all the responses. You know, Charlie and I have been talking about how pressure-directed therapy started, and I think here would be an appropriate nod to talking about the fact that it actually started as an antireflux device, the Surefire system in particular.

 

There have been since the advent of other catheters that are speaking more toward pressure-directed therapy, but just for that person who might not know the nuanced differences between what we're talking about for all these catheters, Surefire in particular started out as an antireflux device. So, the whole point was to protect against non-target embolization of specifically other organs.

 

Now what research has found, and I think is promising, is that when you use these antireflux devices, you actually improve perfusion through the tumor, there are perfusional changes that occur when normal systole and diastole are altered by any antireflux device such as the Surefire. Balloon occlusion devices also do the same, or similar thing.

 

So what I would probably say to someone that doesn't do this that much, is that I would think about it both as an antireflux and as a pressure-directed therapy device. And I probably wouldn't get too caught up in the details except to say: if you feel like you have a patient that isn't - you know, you can't see the mass very well, on angiography, or you feel like you're really try - like it's a small vessel or something like that, and you're gonna have trouble getting in all of your dose, you might try pressure-directed therapy to see if you can actually get all of your dose in, get all of your intended dose in. I think that might be an option for where you might try to use this device.

 

Charlie, what do you think?

 

 

[Charles Nutting]

Yeah, I agree, Nain. I think that probably low-capacitant vessels, when you inject and you don't see the tumor very well, that may be a good indication to use an antireflux catheter to drive more of the therapy deeper into the tumor itself. Perhaps aberrant hepatic anatomy, or you have a gastrohepatic trunk and you want to make sure that you're not gonna reflux into any of the gastric branches, you could place that out into segments two and three, and drive that deeper without that churn for reflux into the stomach; along with situations that you spoke of.

 

 

[Nainesh Parikh]

Anish, I don't know if that answers your question, but you can tell me if I missed anything.

 

 

[Anish Parikh]

Yeah, no, I think it does, I think it does. So now, you know, next time I have a patient present, I'll know what to do, I guess.

 

You know, related to that, talk to me about price, and not even so much ... some folks might question if it's worth it or not, but I'm interested a bit in how do you even make a decision like this? Let's pretend for a moment that we're in a place where... I think what you guys said earlier - correct me if I'm wrong - I think what you said earlier is the data are going in the right direction, but still not necessarily definitive. If you get to a place where the data are definitive, how does cost factor into something like this? Like if I'm a patient, I'm doing everything I can to say I don't care what the price is, you know, if I got a better chance at living here, hook it up.

 

I mean is it that simple or is it more complicated?

 

 

[Nainesh Parikh]

I think it's uh - oh go ahead Charlie, yeah. I'm very interested to hear it.

 

 

[Charles Nutting]

Yeah no it might just be that the therapy and the treatment of the patient is paramount; I don't think the cost should enter into that if we can prove that this is a superior way to treat the patient. So if we have survival and efficacy data, as well as imaging criteria that we're hitting, that show patients do better with this type of therapy, then I think it's a no-brainer. Where it gets a little bit gray is until we have all of that data.

 

But I don't think that it's just a cost-benefit issue, I think it's a 'is the patient going to do better with this therapy, and has that been borne out in the literature?'

 

 

[Nainesh Parikh]

Yeah, so I would agree with it, with I guess probably my own caveat, which is to say, the question is what's better. And I think this is not just specific to this discussion, particularly when you're dealing with oncologic outcomes. The true question of what means 'better' is the one that everybody's trying to answer.

 

So with these patients, all of the discussion we're having is that this is palliative and not curative. The holy grail of any therapy is that it's curative. If you think of the continuum of doing nothing versus doing a therapy that's curative, then where do we fall? Well we know that survival data, when we do liver-directed therapy, is on the order of twelve to twenty-four months - for HCC - of life extension. And so then, within that data, I think the question is how do you look at improved survival, and what's statistically significant, and what makes the most sense?

 

I agree with Charlie completely that therapy and patient outcomes are paramount, and costs shouldn't factor in, in that sense. I could tell you that at our institution, because we are, number one, a conservative place, but number two, all of our purchasing is centralized, and goes through the AT Committee, these discussions are held every day, about what the data shows, how much the cost of the catheter is, things like that.

 

And I think what we'd like to see, what I'd honestly love to see, is that there is a clear benefit. Because once the data bears out that there's a clear benefit, I think then you can start to say, okay, there's an obvious indication here, we need to do more work to prove other indications. But as Charlie said, the cost is not really something that is gonna be prohibited because the patients are going to benefit significantly from this.

 

So, Anish, in my - in our practice, and at our institution, I think, for us, that's why we're probably waiting, so to speak, to hear more data, because, given our practice patterns, we'd love to see a more concise situation. And I know Charlie and I have talked about it, but as an example, one of those indications might be for the guy that's in Tennessee, or even for us, doing two or three of these a day, hypovascular tumors that you otherwise feel are helpless when you're trying to do liver-directed therapy.

 

I'm very excited by the aspect of the thought around therapy for pressure-directed hypovascular tumors, I think it's something that could be great. But I do think that our institution, and for us, and for me, personally, I think about that equation by saying, okay, what's a clear indication, what's a questionable indication, and what do we think we're really gaining here?

 

 

[Anish Parikh]

Final thoughts guys, what do you think we didn't cover that you'd like to share with our audience?

 

 

[Nainesh Parikh]

Yeah, I [do have a question for Charlie, if that's all right.

 

 

[Charles Nutting]

Sure.

 

 

[Nainesh Parikh]

I've only used the Surefire catheter a handful of times, and a couple of those times were in training. What do you think of the actual usage of the catheter? So what I mean is, typically if we talk about tools for a second, since it is a tool ... we go in with a Five French Tig through the groin, or if I'm doing a treatment I go in radial, and I use some other catheter, a SOS, or if I'm going radial, I use a Sarah, and then I'll go microcatheter through that.

 

How do you find the actual tools themselves? Because I know that I asked some folks, and sometimes people complain that the catheter is big, or it's stiff, or it doesn't track, and also complain that you have to use the microcatheter that's supplied by surefire. I'm just curious to know what your experience is.

 

 

[Charles Nutting]

Sure. So I've performed probably a couple hundred procedures with the Surefire devices and different iterations. I think with the precision microcatheter, if I know that I'm going in to do a pressure-directed therapy with radio embolization or drug-eluting beads, then I would use their proprietary guide catheter from the beginning. It's Five French, it'll fit through a Five French sheath, but it's got the larger ID.

 

 

[Nainesh Parikh]

What's the shape of it?

 

 

[Charles Nutting]

I tend to use a Sim 1.

 

 

[Nainesh Parikh]

Oh, so they have a whole array of proprietary microcatheters, got it. Okay.

 

 

[Charles Nutting]

Yes. So they have a C2, a SOS-like, and a Sim 1, and I tend to do most of my liver-directed therapy with a Simmons 1 shape reverse-curve catheter. And I think with the latest generation, the 021 precision catheters, it is very trackable over a wire, and it doesn't change my workflow if I know I'm gonna be using that from the beginning; then I'll use their guide catheter. There is a two to four millimeter device deployment, so it does work in small vessels, and I've been able to use that segmentally, sub-segmentally, and lobar.

 

 

[Nainesh Parikh]

Okay. And I guess my other question - because this is something that I started to think about over the course of the last week as we prepared for this discussion - you know, you have to purchase the guide catheter separately, is that right? They don't come packaged with microcatheters?

 

 

[Charles Nutting]

I believe that's true.

 

 

[Nainesh Parikh]

Okay, so for anyone that wants to try to use this, certainly, I'm sure the Surefire reps will let you know, but just keep in mind that you're gonna wanna have both the guide catheter and the microcatheter available to you.

 

The other thing I'll say: what do you find, if you're parked in a lobar distribution, let's just say in the main right proximal to the take-off of the cystic? Do you find that the catheter is still occlusive enough, so to speak, to change perfusion?

 

Particularly in a guy - let's just make it easier - a guy who's got a hypertrophied hepatic artery because he's got portal vein thrombosis, and you wanna do a lobar right, with a pretty large diameter, in the right hepatic artery.

 

 

[Charles Nutting]

Knowing that from the beginning - probably from doing a mapping/study/CAT scan - I would choose the larger device; they are diameter-dependent devices with smaller and larger, and then there's actually a larger second-generation device that you can use in the right hepatic artery. But I would say, sizing, we've been able to treat some of the larger vessels with the four to six millimeter device.

 

 

[Nainesh Parikh]

Got it.

 

 

[Charles Nutting]

And then, obviously, the smaller ones with the smaller device. I just would say that I haven't had a vessel that was too large to be able to use the device if it was appropriately sized.

 

 

[Anish Parikh]

Got it, yeah.

 

 

[Nainesh Parikh]

Yeah, that's kinda my question, you know, sometimes - and I think that could be another area where this might be beneficial, because I've certainly been in a case where the guy's got a larger diameter vessel, and you've really got no control. I use a tuohy Cantata a lot of times, but you've got no control over where that tip is gonna be located within the vessel. And so if you believe in differences in laminar flow through one of these hypertrophied vessel, you've got even less control over whether or not it's gonna go to the tumor. So I think that's actually probably another exciting area where this could be applied.

 

One last question for the device, Charlie. Do you find that the normal .018 coils go well, if you need to use them? Let's just say you're doing chemo-embo, and you see collateral flow, and you're trying to shut something down. Do you have any problem with putting .018 coils through them?

 

 

[Charles Nutting]

That's a great question, Nain, and I don't know that they're really designed to be delivering coils through. I have done that, and there's an 025 ID, and an 021 ID; I have been able to do that, but I would say if you're gonna be doing coiling, I'd probably do that through a separate microcatheter, and then use the Surefire device after you've embolized.

 

One thing I would say is that they do have a one hundred fifty centimeter length that we've used radially.

 

 

[Nainesh Parikh]

Well I guess that's it for my questions.

 

 

[Anish Parikh]

Okay. And anything on your side, Charlie?

 

 

[Charles Nutting]

No, I just think it's important for interventional radiologists to realize that the tumor microenvironment is very complex, and there's the interstitial matrix of the tumor, there are interstitial pressure in the tumor that are probably above systolic pressure. So I think some of these devices can help us deliver therapy deeper into the tumor and probably get homogeneous coverage.

It's not just a ball of cancer cells, there's a lot of complex physiology that's actually going on. So I think anything we can do to take advantage of delivering more product or more therapy in the area of the tumor is potentially helpful.

 

 

[Nainesh Parikh]

I mean, I totally agree with Charlie, I think we're probably on the tip of the iceberg with any deliver-directed therapy. I think there's a lot more work to be done, and I think what hopefully we'll find is that, as we find out more about pressure-directed therapy, we'll get to know the details about the types of devices, the types of catheters, the types of ways to deliver pressure-directed therapy, and how we can improve that. I mean, I'm excited about the innovations that are coming down the pike.

 

 

[Anish Parikh]

Well thanks again to Surefire Medical, the sponsors of our podcast. Learn more at surefiremedical.com.

 

And thanks as well to Doctor Nainesh Parikh and Doctor Charlie Nutting. I really appreciate you guys being on here and sharing your thoughts with us.

 

 

[Charles Nutting]

Thank you very much.

 

 

[Nainesh Parikh]

Thanks for having us.

 

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